The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories: Drug Recall
Recall #D-0324-2024 · 02/09/2024
Class II: Risk
Recall Details
- Recall Number
- D-0324-2024
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Status
- Terminated
- Date Initiated
- 02/09/2024
- Location
- La Vergne, TN, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 8,198 units
Reason for Recall
an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Product Description
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Pharmaceuticals, Inc. Eatontown, NJ, Distributed by Major Pharmaceuticals Livonia MI. NDC 0904-6440-61
Distribution Pattern
The product was distributed nationwide within the United States.
Other Recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
- Class II: Risk 09/12/2025
View all recalls by The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories →
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.